BN5208

Biomedical Quality and Regulatory Systems

Mrinal Kanti, PhD

Department of Biomedical Engineering
National University of Singapore
 What we will learn today…

• Practice MCQs to ensure you understood and retained what was taught last lecture 
• Updated schedule
• Discussion on post-lecture presentations
• De Novo pathway
• Going over some concepts from previous class like predicate devices, 510k and PMA
processes
• Different regulatory bodies worldwide
• About European union
• EU directives for medical devices
• Risk classification
• CE certification process
• Classification of medical devices in Singapore
• Regulatory framework of Singapore
 Updated Schedule
Week Topics covered Notes Instruction mode
1 Introduction, what is and what is (not) a medical device, Role and Face-to-Face (F2F)
characteristics of a Regulatory professional
2 Project discussion, FDA classification of medical devices, FDA classification F2F
of Tissue Engineered product
3 Med device regulation in other jurisdictions (Singapore, EU) F2F

4 Conformity assessment, AI in medical devices Group presentation 1-4 F2F

5 Project management, Ethics in device regulations (case studies) Group presentation 5-8 F2F

6 Salient features of devices, biocompatibility and design issues Group presentation 9-10 F2F

Recess week No lectures

7 Commercialization of medical devices, audits, Post market obligations and Blended Learning
processes; surveillance and vigilance (recorded)
8 Guest Lecture (pending confirmation) Blended Learning/Zoom

9 Quality system regulation, compliance and risk analysis and management, Group presentation 11-15 F2F
product recall, global regulatory strategy
10 CA Quiz (MCQs and closed book) F2F

11 Self Study No lecture

12 Project Final Presentations Gps 1-8 F2F

13 Project Final Presentations and Final report submission Gps 9-15 F2F

Schedule subject to change depending on availability of guest lecturers and travel needs
 Post lecture
presentation details
Lets learn together
(post-lecture presentations)

Transcyte (Group 1)
Carticel (Group 2)
Apligraf (Group 3)
FocalSeal (Group 4)
 Lets learn together
• Inspiration/unmet medical need
• Target audience
• Current standard of care for similar medical condition
• Commercial aspect/considerations
• Product details
• Principle and mechanism (how it functions)
• Clinical trials ?
• Issues with FDA ?
• Limitations and Side Effects
• The next better thing…
• Any other relevant and interesting aspect you wish to share

• 7-8 minutes (max) per group followed by QnA/discussion

• 2-3 members can present the post lecture presentations and the rest of the
team may present the final presentations (only 1 presentation per person)
• Please save your presentation in a thumb drive if possible for quick transition
Objective: To encourage individual and peer-to-peer learning which is typically followed in an industrial
setting where small groups working together come up a potential suggestion/brainstorm 6
 Individual group Zoom meet up
(6th September)

Rationale:
• To answer any questions you may have on the project/report
as well as on materials and contents covered thus far… All is
fair game…
• Provide additional avenues for shy (not so vocal) students,
who are unable to ask questions during regular lecture
sessions
• If any group prefers a different day/time, please let me know.
• It is optional, but only if anyone has any questions on the
materials covered thus far 
• Every group to log in at their respective time
 Extra feedback/consultation schedule- I
Groups Friday, 6th September Groups Friday, 6th September
1 11-11.10am 16 2-2.10pm
2 11.10-11.20am 17 2.10-2.20pm
3 11.20-11.30am 18 2.20-2.30pm
4 11.30-11.40am 19 2.30-2.40pm
5 11.40-11.50am 20 2.40-2.50pm
6 11.50-12 21 2.50-3pm
7 12-12.10pm 22 3-3.10pm
8 12.10-12.20pm 23 3.10-3.20pm
9 12.20-12.30pm 24 3.20-3.30pm
10 12.30-12.40pm 25 3.30-3.40pm
11 12.40-12.50pm 26 3.40-3.50pm
12 12.50-1pm 27 3.50-4pm
13 1-1.10pm 28 4-4.10pm
14 1.10-1.20pm 29 4.10-4.20pm
15 1.20-1.30pm

Zoom link:
https://nus-sg.zoom.us/j/3104119186?pwd=V2pCcXRCQ2hZUHZkRWE5ZjVYam5xdz09
Practice questions from
previous week
Some additional concepts from
last lecture
 De Novo pathway
For new/novel (potentially ground breaking) medical
devices, which previously have not been designated a class
(as they are new), but are ascertained to be low to medium
risk, the De Novo pathway is appropriate…

Previously (prior to DeNovo) they were being placed in Class III, requiring
significant patient data and thus enhanced time to market…which FDA
felt was not appropriate

De Novo devices are those for which general and special “controls”
provide a “reasonable assurance” of the device’s safety and effectiveness,
even though there are no legally marketed devices of the same type

EG: Specific Insulin pumps and Hearing aids

 Predicate device is a legally marketed device used
for comparison to determine safety and efficacy

Substantial equivalence
• Both devices have same intended use
• New devices have same/very similar technology

Hint: Emphasis on similar usage/clinical outcomes

achieved and thereafter technology similarity
 Content of a 510(k) submission

CDRH submission cover A standardised cover sheet that can be used to record basic information on all pre-market
sheet submissions to the CDRH
Covering letter Identifies the device and gives a brief outline of the device

Table of contents

Statement of substantial Identifies reference device or standard and rationale for claiming equivalence/conformity
equivalence/conformity
Labelling Copies of labels, instructions for use or user manuals or other relevant information

Comparative information Data demonstrating equivalence and performance. May also include information from
predicate device to show equivalence of claims, etc.
Biocompatibility assessment Data establishing the biocompatibility of the materials
(if applicable)
Truthfulness and accuracy A signed declaration by a responsible person for the submission as to the truthfulness and
statement accuracy
Shelf life (if applicable) Data establishing the stability of the device, accelerated stress data are acceptable

Indication for use form Formal clarification of the indications for use, which will be made available to the public

510(k) Summary A summary of the submission, which will be made available to the public
 Content of a PMA application

Table of contents summary Indications for use, device description, alternative practices, and procedures currently
available for the condition, marketing history (US or foreign), non-clinical laboratory
studies, clinical investigations, and overall conclusions.
Device description and Detailed drawings and description of device and methods used for manufacture and
manufacture control of the device.

Technical sections (pre- Non-clinical laboratory studies used to investigate microbiological, toxicological,
clinical and clinical data) immunological, biocompatibility, stress, wear, shelf life, and other characteristics of the
device.
Data from clinical investigations on human subjects, plus statements as regards
investigators, IRBs, and informed consent.
Device samples (on request) Provide samples of the device or a location where they may be tested by the FDA.

Copies of labelling Labels, instructions for use, user manuals, etc.

 Content of a PMA application

General
requirements
Safety Devices to be designed and manufactured so as not to compromise the safety of
patients or users. Any potential risks must be acceptable when weighed against the
benefits to the patient and be compatible with a high level of protection of health and
safety.
Effectiveness The devices must be designed and manufactured in such a way that they will deliver
their intended performance under the recommended condition for use.
Risk management The design and construction of devices must adhere to the following safety principles:
– eliminate or reduce risks as far as possible (inherently safe design and
construction),
– where appropriate take adequate protection measures in relation to risks that
cannot be eliminated (eg battery powered devices),
– inform users of the residual risks due to any shortcomings of the protection
measures adopted.
Stability The devices must retain their performance characteristics over their claimed lifetime
under the normal stresses associated with their use.
The devices must be designed, manufactured and packaged so as to maintain their
performance characteristics under the intended conditions of transport and storage.
 Content of a PMA application

Design and construction

/manufacturing requirements
Choice of materials Bio-compatibility data. Measures to prevent infection from devices containing
materials of biological origin.
Devices utilising a power source Protect against electrical shocks (device and/or connections). Avoid interference with
or by other devices (electromagnetic interference, etc.).
Ensure the reliability of power source and/or software. Protect against thermal or
mechanical risks.
Devices with a measuring function Ensure accuracy and stability of results. Use SI units.
Establish traceability to reference materials/standards.
Protection against radiation (lasers, Adopt measures to limit exposure of users or patients to radiation. Provide adequate
X-ray, etc.) control features and instructions to ensure safe administration of the intended
exposure.
Sterile devices Validate packaging and sterilisation procedures to ensure sterility.

Devices used in combination with Consider the performance of the overall system
other devices or equipment
Information supplied by the Provide mandatory information on labels and instructions for use (specified according
manufacturer to directive/type of device). Use symbols on labels.
U.S. Classification of Medical Devices

Medical devices vary widely in their complexity and their degree of risk or benefits.
Thus, U.S. FDA places all medical devices into one of three regulatory classes based
on the level of control necessary to assure safety and effectiveness of the device.

Class I = General Controls

Class II = General Controls and Special Controls (510k)
Class III = General Controls and Premarket Approval (PMA)

Of the appx 1,700 classified devices, about 45% are Class I, 47% are Class II and 8%
are Class III.
• USA: US Food and Drug Administration (FDA)
• Singapore: Health Science Authority (HAS)
• Australia: Therapeutic Goods Administration (TGA)
• Canada: Health Canada
• China: National Medical Product Administration (NMPA)
• Europe: European Medical Agency (EMA) and European Commission
• Japan: Pharmaceuticals and Medical Devices Agency (PMDA)
 List of member states of the European Union

Year of entry Member states

into the EU
1958 Belgium, France, Germany, Italy, Luxembourg, the Netherlands

1973 Denmark, Ireland, the United Kingdom

1981 Greece

1986 Portugal, Spain

1995 Austria, Finland, Sweden

2004 Czech Republic, Cyprus, Estonia, Hungary, Latvia, Lithuania, Malta, Poland,
Slovak Republic, Slovenia
2007 Bulgaria, Romania

2013 Croatia

The European Union member countries facilitate the free movement of goods (including medical devices).
Medical devices bearing the CE mark are cleared in the European Union market. The European Economic Area
(EEA) was established on 1 January 1994 following an agreement between the member states of the European
Free Trade Association (EFTA) and the European Community: Iceland, Liechtenstein and Norway are allowed to
participate in the EU’s Internal Market without a conventional EU membership. In exchange, they are obliged to
adopt all EU legislation related to the single market (including for Medical Devices). One EFTA member,
Switzerland, has not joined the EEA; CE marking of Medical Devices is, however, recognized in Switzerland by
means of a Mutual Recognition Agreement (MRA) between the EU and Switzerland.
 Medical Devices Directives
The European Directives have to be transposed into national law by each member state in
order to integrate the content of these directives into laws and regulations without major
modification (Changes which conflict with EU Directive are not acceptable)

Date of Designation Scope Examples

enforcement
1990 Directive on Active Active Cardiac
Implantable Medical Implantable Pacemaker,
Devices Directive (AIMDD) Medical defibrillator
Devices
1993 Medical Device Medical Sutures,
Directive (MDD) Devices syringes
1998 Directive on In Vitro In Vitro Blood
Diagnostics Medical Diagnostics collection
Devices Directive (IVDMDD) Medical system, Petri
Devices dishes

Because the regulations are harmonized, MD bearing the CE marking may circulate freely through
out EU (although some countries may have additional conditions/barriers to market)
 Transition from EU MDD (medical device
directive) to EU MDR (medical device
regulation)

• Gradual transition from MDD to MDR implemented

• Not significantly different, but more emphasis on
safety, documentation, UDI (unique device
identifier), PMS (post market surveillance)
• Essentially an extension of MDD…
 Active Implantable Medical Devices
The active implantable medical devices are at maximum risk: by definition they are
any active medical device which is intended to be totally or partially introduced,
into the human body and which is intended to remain after the procedure.

Examples of active implantable medical devices

• Implantable cardiac pacemakers
• Implantable defibrillators
• Leads, electrodes, adaptors
• Implantable nerve stimulators
• Bladder stimulators
• Implantable active drug administration device

By default, all accessories to AIMDs are covered under AIMD themselves.

In vitro and Diagnostics Medical Devices

• The classification of in vitro and diagnostics medical devices is based on

the risk of usage. If they are to be used by healthcare professionals, they
are classified with lower risk, and thus exempt from independent pre-
market approval and placed on the market based upon the manufacturer’s
self-declaration that the device comply with the requirements of the
Directive.

• When they are of higher risk and/or intended to be used by home user for
self-testing, they require a premarket design examination from a notified
body.
 EU regulations: Competent Authority (CA)

The competent authority or regulatory authority is a government agency (of individual

EU country) that exercises a legal right to control the use or sale of medical devices
within its jurisdiction. It has the ability to take enforcement action to ensure that
medical products marketed within its jurisdiction comply with legal requirements.

Its roles and responsibilities are as follows:

• indicates and inspects the notified bodies
• supervises the market
• centralizes and evaluates the vigilance data and works on disputes

Following are the examples of competent authority:

• United Kingdom: MHRA (Medicines and Healthcare Products Regulatory Agency)
• France: AFSSAPS (Agence Francaise de Securite Sanitaire des Produits de Sante)
 EU regulations

Authorized Representative (AR): Individuals or legal entities appointed by manufacturers who

do not have a registered place of business in Europe to act as regulatory contact for the
competent authorities. The AR must be established inside the EU. AR may be addressed by
authorities and Notified body instead of the manufacturer with regard to the latter’s
obligations

Notified Bodies (NB): Independent entities, eg testing labs, certification organizations

appointed and accredited by Competent Authority to conduct conformity assessment
procedures of medical device companies to ensure compliance relevant regulation. Most
manufacturers need to be audited by a NB unless the manufacturer only manufactures Class I
(non sterile, non measuring) devices. The manufacturer calls upon the notified body of choice:
more than 76 registered notified bodies in Europe.

DoC: Declaration of conformity; is a document that a manufacturer must submit to

appropriate authorities stating that it conforms to the essential requirements of the
regulations
 Lets think…
If a med dev ‘X’ been approved by competent
authority in country ‘A’, will it be
automatically/legally approved for sale in
country ‘B’, within the EU

Hint: Eligible to market vis-a-vis right to market

 Legal Manufacturer (LM)
• The legal manufacturer is legal person/entity with responsibility for the design, manufacturing,
packaging and labelling of a device before it is placed on the market under its own name,
regardless of whether these operations are carried out by that person/entity or on behalf by a
third party

• The manufacturer must ensure that it is manufactured to meet or exceed the required standards
of safety and performance.

• The legal manufacturer is responsible of all the operations necessary to design, manufacture, label
and package the product throughout its lifecycle from design to distribution to the final customer.
The legal manufacturer is responsible to choose the notified body and affixing the CE mark on the
product once it is obtained.

• The manufacturer has an obligation to ensure that a product intended to be placed on the
Community market is designed and manufactured, and its conformity assessed, to the essential
requirements in accordance with the relevant provisions.

• The manufacturer may use finished products, ready-made parts or components, or may
subcontract these tasks. However, LM must always retain the overall control and have the
necessary competence to take the responsibility for the product
Risk base EU classification of Medical Devices

Medical devices are primarily divided into four classes — Class I,

Class IIa, Class IIb, and Class III — according to the level of risk
the device as based on the following criteria:

• duration of use (transient, short term, long term)

• active/non-active (energy sources like battery)
• implantable
• specific hazards (e.g. contact with the central nervous system,
animal tissues, absorbable material, ionizing radiation etc)
Examples of medical devices per class
Class Risk Examples

Class I Low risk • Surgical instruments

• Non-invasive tubing to evacuate body liquids
• Examination gloves/masks
• Hospital beds
Class Is Low risk (sterile) • Sterile body liquid collection devices
• Sterile absorbent pads
Class Im Low risk (with a • Syringe without needle (graduated barrel)
measuring function) • Device for measuring body temperature
• Device for measuring intra-ocular pressure
Class IIa Medium low risk • Syringe with needle
• Tubing intended for use with an infusion pump
• Non-medicated impregnated gauze dressings
• Short term corrective contact lenses
Class IIb Medium high risk • Hemodialysers
• Long term corrective contact lenses
• Urinary catheters intended for long term use
• Insulin pens
Class III High risk • Neurological catheters
• Prosthetic heart valves
• Pre-filled syringe for vascular access device
• Spinal needle
• Absorbable/resorbable sutures
EU Medical device and IVD classification
 CE Mark… the eventual goal
• The CE mark is the proof from the manufacturer that the product is in
conformity with the regulations.

• CE marking attests that the products are in conformity with the

essential requirements of the applicable directives and that the
products were subjected to the procedure of conformity evaluation
envisioned in the directives.

• CE marking is affixed before marketing the product.

• CE marking allows freedom of movement of the medical device in the

territory of the European Union.
 Conformite Europeenee

Not to say that the product is ready for marketing but rather the
product conforms to established directives/regulations
 Medical Device Classification By the Legal Manufacturer

Notified Body identification

Self certification by legal
manufacturer
Conformity assessment procedure
selection by legal manufacturer

Technical documentation
review by notified body
Batch verification
by notified body Steps to CE
Quality management system
verification by notified body
marking
CE mark certificate delivered
by notified body

Class I
Class Is, Im, IIa, IIb, III

Plus identification number of

the Notified Body

Continued batch verification CE declaration of conformity issued by legal manufacturer

by notified body
 Implications on Manufacturer (most
affected by; MDD to MDR)
Manufacturers bear the biggest burden in ensuring compliance to the
regulations. Article 10 lists manufacturers’ general obligations, explaining
what they need to do, and the Annexes explain how they need to do it. Here
is a summary of the responsibilities:

• Conduct clinical evaluations, including post-market clinical follow-ups

• Declaration of Conformity written and affixed to CE marking of conformity
• UDI compliance
• Establish a system for risk management
• Ensure incidents and field safety corrective actions are recorded and reported
• Cooperate with competent authority to provide information or product samples as needed
• Ensure processes are in place to manage compensation claims for damages caused by a
defective device
• Implement a postmarket surveillance program and ensure it is up to date
• Ensure devices are accompanied by all relevant information in the languages determined
by the member states where each device is available. The label shall be indelible, easily
legible, and clearly comprehensible to the intended user or patient.

It is a bit more complex but I have tried to put it in simpler terms to facilitate your understanding
 Some fundamental points for
comparing EU/US Medical Device
Legislation

36
 Purpose
• EU • USA
• European Treaty • To promote inter-state trade
• Requirements to allow medical • Requirements to allow medical
devices to be traded across the devices to be traded across
Member States without trade individual States
barriers

Authorities
• Legal authority: 28 Competent • Legal authority: FDA
Authorities
• Approval (PMA): FDA
• Vetting compliance with ER: 60
• Notification (510k): FDA
Notified Bodies
• Authority which can prosecute
• Authority which can prosecute
you: FDA
you: Competent Authorities
37
 Content
EU USA
• Sets out Essential Requirements • Sets out Pre-Market Approval
(ER) which all devices must meet (PMA) requirements and confers
• Lists procedures through which Pre-Market Approval
manufacturers can demonstrate • Sets out Substantial Equivalent
compliance with ER (SE) process and issues SE
• Manufacturer makes Declaration Notification
of Conformity
Routes to market
• EU: seven different routes • PMA (Pre market approval)
covering • 510(k) Notification
– Active implantables
– Medical devices
– In vitro diagnostic medical
devices 38
 Process

EU USA
• Manufacturer (M) classifies • FDA specifies classification
device (four classes) • FDA specifies route - PMA or 510(k)
• M chooses route • PMA: FDA specifies tests etc to be
• M does work to demonstrate carried out
compliance with ER • 510(k): M demonstrates this device
like another already on the market
• Notified Body assesses
• FDA writes Approval (PMA) or
compliance Notification (510k)
• M writes DoC

39
 Compliance (simplified!)

EU USA (510 k)
• Notified Body carries out on-site • FDA examines technical
audit submission
• Checks QMS & Tech File • Issues ‘notification letter’
• Issues certificate • Marketing product
• Declaration of Conformation by M • At sometime later (2-4 years) on
• Marketing product site inspection of QMS
• Post market surveillance required

40
Singapore: Medical Device
Regulatory System
 HSA (Health Science Authority)
Formed April, 2001 and comprises of:
• Health product regulation group
• Blood services group
• Applied science group

HSA passed Health products act (HPA) in 2007. The

objectives are:
• Mandatory registration of all med devices
• Any dealer in med dev (manufacturer, importers etc) has to be
registered
• Post market responsibilities
Singapore Health Sciences Authority (HSA), Medical Device Branch, is entrusted
with regulating medical devices in Singapore. HSA has adopted the new regulatory
system based on the principles endorsed by the Global Harmonization Task Force
(GHTF) with modification to suit the Singapore context.

In general, the regulatory framework for medical devices in Singapore is mapped

in order to safeguard public health but without unduly restricting consumer
choices and their access to new technologies.

In 2002, HSA introduced the Voluntary Product Registration Scheme and post-
market monitoring and surveillance program for medical devices in the Singapore
market. With the passage of the Health Products Act 2007 in February 2007, HSA
implemented the Health Products (Medical Devices) Regulations to further
strengthen the control of medical devices in local market.
Implementation phases of the regulatory control

November 1, November August 10, January 1, 2012

2007, onward 1, 2008, 2010
onward
Phase 1 Phase 2 Phase 3A Phase 3B

Imposition of duties Acceptance of license Only licensed dealers Unless authorized by HSA,
and obligations on application of parties shall manufacture, all classes of MDs are
dealers: dealing with MD import and supply MDs prohibited from supply
• Report product Acceptance of unless authorized by (Class A, B, C, D) MDs
defects and AEs Registration of Class HSA or listed on the licensed under Radiation
• Recall product upon C, D (Transition Transition list, all Protection Act, NEA —
HSA instructions list/registered) Unregistered Class C, D August 1, 2011
• Keep distribution MDs are prohibited
Records from supply
Classification of Medical Devices (Classes A,
B, C, and D)
Principle
Regulatory control is proportional to the level of risk associated with a medical
device, which increases with higher degree of risk involved. Therefore, medical
devices are classified on the basis of their risk to patients and users substantially
on its intended purpose and effectiveness of the risk management techniques
applied during design, manufacture and use.

Classification
Various factors contribute to the risk classification of medical devices, which
includes:
• duration of medical device contact with the body
• degree of invasiveness
• delivery of medicinal products or energy to the user
• intended to have biological effect on the user
 Risk classification system for medical
devices In Singapore

Risk class Risk level Medical device examples

A Low risk Surgical retractors/tongue depressors
B Low-moderate risk Hypodermic needles/suction
equipment
C Moderate-high risk Hip implants/bone fixation plate
D High risk Heart valves/implantable central
nervous system (CNS) stimulator
Product Registration for Higher Risk Medical
Devices (Class B, C, and D)
• Assoc. of Southeast Asian Nations (ASEAN), Common Submission Dossier
Template (CSDT) template is to be used for submission to HSA.
• All product registration applications to be submitted via the online Medical
Device Information and Communication System (MEDICS).
• Upon successful submission, the application will be screened before it can be
accepted for evaluation to minimize any major deficiencies
• The evaluation decision will be made on the basis of the evaluation outcome of
the submitted information, i.e., registrable, rejection.
• For medical devices that receive a “Registrable” evaluation decision, the
registrant may submit an application to list the medical device on the SMDR
(Singapore Med Dev Register).
Product Registration for Lower Risk Medical Devices
(Class A)

Submission in Common Submission Dossier Template (CSDT) is not required for Class A
medical devices.

The data requirement for Class A medical devices

• Letter of Authorization
• Singapore Declaration of Conformity
• Copies of product labeling, i.e., instructions for use, brochure, label, etc.
• Name, address, and contact information for all authorized importers
• Quality management system certificate for the manufacturing site and sterilization
site (if applicable)
• Sterilization method and sterilization validation standard(s) used (if applicable)

Additional requirement for Class A, in vitro Diagnostic (IVD)

• List of all materials and source of animal, human, microbial, and recombinant origin
used in the IVD medical device.
Routes to registration for Class B, C and D
classes

• Full Evaluation Route:

• Letter of authorization
• CSDT should include:
• Summary
• Declaration of conformity
• Device description
• Design verification and validation
• Labelling
• Risk management
• Manufacturing facility

• Abridged method:
• If it is approved in either; USA, EU, Australia, Japan, Canada
 Country Regulatory agency/body National healthcare
policies/laws/regulations
US FDA Food, drug and cosmetics act and its
• Center for devices and radiological amendments
health (CDRH)

EU European commission MDR

• National competent authorities IVDMDR
• Notified bodies
AIMDR

Singapore HSA Health products act and its amendments

AIMDR: active implantable medical device regulation

IVDMDR: in vitro diagnostics medical device regulation
MDR: medical device regulation

The level of complexity and burden on medical device market clearance process is
defined by the controls established in the country of interest
 Some take home massages…

• Device classification for EU and Singapore is also risk based like FDA;
only that the nomenclature is little different

• Of the appx 1,700 FDA classified devices, about 45% are Class I, 47%
are Class II and 8% are Class III

• EU has three directives to classify Med Devices

• The CE marked product conforms to established EU med dev

directives MDD, IVDD and AIMDD

• HPA was enacted by HSA in 2007

 References

• Tobin JJ, Global marketing authorisation of biomaterials and medical devices

• Raps.org
• Wong et al. Med Dev RA in Asia
• https://www.hsa.gov.sg/
• https://www.biosliceblog.com/2017/09/mhras-guide-new-eu-medical-device-regulations/